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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD ALARIS PRIMARY IV TUBING SET, ADMINISTRATION, INTRAVASCULAR

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BECTON DICKINSON AND COMPANY BD ALARIS PRIMARY IV TUBING SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2420-0007
Device Problems Device Displays Incorrect Message (2591); Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2020
Event Type  malfunction  
Event Description
Iv tubing bulging in the chamber of the alaris pump. It was beeping ¿occluded¿ and then when door opened, bulging tubing was noted. Fda safety report id # (b)(4).
 
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Brand NameBD ALARIS PRIMARY IV TUBING
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
franklin lakes NJ 07417
MDR Report Key9769736
MDR Text Key181635546
Report NumberMW5093360
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
Device Catalogue Number2420-0007
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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